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Please note: using the search filters may not provide accurate search results for records prior to November 2021. When searching for older records, please ensure that you use the include archive checkbox.

Displaying 1 - 15 of 273 items.

Health alert or recall Aquac Uno H Reverse Osmosis System - Main Unit
On June 14, 2022, the manufacturer Fresenius Medical Care Ag & Co. Kgaa notified Fresenius Medical Care Canada, Inc. that during regular quality inspections of Aquac Uno H devices, it was discovered that the internal ethernet cable had not been…
RecallHealth product recall | 2022-06-27
Health alert or recall Fingertip Pulse Oximeter
Voluntary recall-interim order authorisation not approved. Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Infrared Thermometer
Voluntary recall-interim order authorization not approved.  Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Digital Thermometer
Voluntary recall- interim order authorisation not approved. Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Epoc Blood Analysis Bgem Test Cards
Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. at a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-…
RecallHealth product recall | 2022-06-20
Health alert or recall Minimed Pump battery cap
Notification to inform customers of a potential issue relating to pump's battery cap and provide actions required by the customers. Notification advises customers that if the metal contact becomes loose or falls off from the…
RecallHealth product recall | 2022-06-13
Health alert or recall Yelloport Elite Universal Seal
During the manufacturing process, there is a slight risk of the formation of a hole in the sterile packaging which typically forms near the pre-sealed area at the bottom of the sterile packaging of the Yelloport Elite Universal Seals. Recall start…
RecallHealth product recall | 2022-06-13
Health alert or recall Nucleus 7 Processing Unit
This failure mode has potential to manifest for all devices manufactured with apple MFi keys in the range 6100 to 6103 when attempted to pair with iOS devices. Complaints to date have come from CAM, APAC and EMEA regions. This issue is isolated to cp1000…
RecallHealth product recall | 2022-06-13
Health alert or recall KN95/FFP2 Particulate Respirator Mask - Model 516W
Unauthorized KN95/FFP2  particulate respirator mask - do not use as a respirator.  Recall start date: May 10, 2022
RecallHealth product recall | 2022-06-07
Health alert or recall 1 Series Phototherapy Device
Software update required. a change was made to v3.00 (released june 30, 2021) to update bit11 in HST file flag. This was done for compatibility with clearlink website- discovered 0inch/9inch inconsistency when testing for Arcutis clinical trial data…
RecallHealth product recall | 2022-06-07
Health alert or recall Poch-Pack L
The encrypted barcode data generates an error that prevents the analyzer from using the entire contents of the bottle. The user is required to replace the reagent container prematurely. On 4/25/22, the issue was identified through the trending of post…
RecallHealth product recall | 2022-05-30
Health alert or recall Ortho Connect
An end user site attempted to perform QC on a single test using multiple QC kits. The QC module was not designed to support testing of multiple QC kits for a single test, and it is required that all QC samples used to validate a test are contained in a…
RecallHealth product recall | 2022-05-30
Health alert or recall Pagewriter Electrocardiograph
The pagewriter tc30/50/70 cardiograph device could potentially fail to charge while plugged into the ac power outlet. This is due to a faulty mainboard. based on a supplier analysis, the faulty mainboard was caused by…
RecallHealth product recall | 2022-05-30
Health alert or recall Alliance Earloop Procedure Mask
Mold was found in lot Y591676 of the product. Two species of mold were identified that could pose a potential health risk to users. Recall start date: May 3, 2022
RecallHealth product recall | 2022-05-30
Health alert or recall Surestrips Rapid Response Covid-19 Antigen Rapid Test Device
Surestrips Rapid Response Covid-19 Antigen Rapid Test Device are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e.…
RecallHealth product recall | 2022-05-30
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